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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002388
Receipt No. R000002870
Scientific Title A multicenter phase II study of FOLFIRI as first-line chemotherapy for metastatic colorectal cancer with reduced starting dose of irinotecan in patients with homozygous for UGT1A1(FLIGHT1)
Date of disclosure of the study information 2009/09/01
Last modified on 2018/09/20

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Basic information
Public title A multicenter phase II study of FOLFIRI as first-line chemotherapy for metastatic colorectal cancer with reduced starting dose of irinotecan in patients with homozygous for UGT1A1(FLIGHT1)
Acronym A multicenter phase II study of FOLFIRI for metastatic colorectal cancer(FLIGHT1)
Scientific Title A multicenter phase II study of FOLFIRI as first-line chemotherapy for metastatic colorectal cancer with reduced starting dose of irinotecan in patients with homozygous for UGT1A1(FLIGHT1)
Scientific Title:Acronym A multicenter phase II study of FOLFIRI for metastatic colorectal cancer(FLIGHT1)
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Surgery in general
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The objective of this study is to evaluate the tumor response rate and the incidence and severity of adverse events during first-line chemotherapy with FOLFIRI in patients with metastatic colorectal cancer .
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes (1)response rate
(2)incidence and severity of adverse events
Key secondary outcomes (1) Determination of the time to response, the duration of response, the progression-free survival (PFS) time, and the overall survival (OS) time.
(2) Evaluation of the causal relationship of each adverse event with the protocol treatment, its reversibility, its cumulative dose-response relationship, and its course over time.
(3) Detection of genetic variation (when possible) and correlation of genetic variations with the pharmacokinetics of CPT-11, SN-38, and SN-38G as well as with the toxicities of CPT-11 (as an ancillary investigation).

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Gene
Interventions/Control_1 On Day 1, patients treated with FOLFIRI therapy received a 2-hour intravenous infusion of CPT-11 (150 mg/m2) combined with 1-LV (200 mg/m2), followed by a rapid intravenous infusion of 5-FU (400 mg/m2), and then a 46-hour continuous infusion of 5-FU (2,400 mg/m2). This regimen comprised one course of therapy and was repeated once every 2 weeks. Cycles of treatment will be continued for this study until disease progression (PD) occurs.
Patients will undergo UGT1A1 genotyping before starting to receive the protocol treatment. As recommended in the US prescribing information for Camptosar;, the starting dose of CPT-11 will be reduced to 100 mg/m2 in patients who are homozygous for the *28 allelic variant of UGT1A1 (further reduced to 75 mg/m2 in such patients aged 76-80 years). No dose adjustments will be made in patients who undergo UGT1A1 genotyping after starting to receive the protocol treatment.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria (1) Histopathologically diagnosed colon carcinoma or rectal carcinoma.
(2) Advanced or recurrent disease that is not amenable to curative resection.
(3) No history of chemotherapy, immunotherapy, or radiotherapy (including palliative local radiation).
(4) At least 4 weeks after surgery.
(5) ECOG performance status of 0-1.
(6) Age between 20 and 80 years (inclusive).
(7) Life expectancy of at least 12 weeks.
(8) Presence of at least one measurable lesion (outside the radiation field). A measurable lesion is defined as one that can be measured in a single dimension by palpation (together with a scale-containing radiographic image that permits objective assessment of the lesion size), CT, MRI, or any other radiographic method and which has a larger diameter >=2 cm (or >=1 cm and >=twice the slice width when measured by MRI or spiral CT).
(9) Adequate function of vital organs (e.g., bone marrow, heart, lungs, liver, and kidneys), as demonstrated by laboratory data obtained within 14 days of enrollment that are in the following ranges:
White blood cell count: 3,000-12,000/mm3.
Neutrophil count: >=1,500/mm3
(calculated from the white blood cell count and the differential neutrophil count [%]).
Platelet count: >=100,000/mm3.
Serum bilirubin: =<1.50 mg/dL.
AST and ALT: =<100 IU/L or 100 U/L.
Serum creatinine: =<1.20 mg/dL.
(10) Personally signed and dated written informed consent to participation in this study (including submission of biological specimens) prior to enrollment.
Key exclusion criteria (1) Blood transfusion, administration of blood products, or hematopoietic (e.g., G-CSF) support within 7 days before enrollment.
(2) A history of severe drug allergy.
(3) Pleural effusion, ascites, or pericardial effusion requiring drainage.
(4) Concurrent active (e.g., clinically significant) infection.
(5) Confirmed or clinically suspected brain metastasis.*1
(6) Involvement of the central nervous system.
(7) Presence of bone metastasis as the sole metastasis.
(8) Any other concurrent malignancy, excluding metachronous malignancy that has been confirmed to have been cured.*2
(9) Uncontrolled hypercalcemia.
(10) Uncontrolled hypertension (despite antihypertensive medication).
(11) Uncontrolled diabetes mellitus.
(12) Any significant electrocardiographic abnormality or clinically significant heart disease.*3
(13) Fresh gastrointestinal bleeding.
(14) Intestinal paralysis or obstruction.
(15) Diarrhea (watery stools).*4
(16) Positivity for HIV antibody.
(17) Current treatment with atazanavir sulfate.
(18) Current treatment with phenytoin, warfarin potassium, or flucytosine.
(19) Pregnant or breast-feeding women, women of childbearing potential, women who wish to become pregnant, or men who wish to have a child with their female partners.
(20) Current participation in any other clinical trial/study.
(21) Any other condition that disqualifies the patient from the study in the opinion of the investigator.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideyuki Mishima
Organization Aichi Medical University
Division name Cancer Center
Zip code
Address 1-1, Yazakokarimata, Nagakute, Aichi
TEL 0561-62-3311
Email hmishima@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mai Hatta
Organization Nagoya University Graduate School of Medicine
Division name Young Leaders&#39;Program
Zip code
Address 65 Tsurumai Showa-ku Nagoya
TEL 052-744-2442
Homepage URL
Email m-hatta@med.nagoya-u.ac.jp

Sponsor
Institute NPO Epidemiological and Clinical Research Information Network
Institute
Department

Funding Source
Organization NPO Epidemiological and Clinical Research Information Network
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
RESULTS: 

After a median follow-up period of 22 months, complete response was achieved in 1.9%, partial response in 38.5 %, stable disease in 51.9% and progressive disease in 3.9%. The overall response rate was 40.4%, the disease control rate was 92.3% and the median overall survival time was 22.3 months. The major toxicity was grade 3-4 neutropenia in 44.2%. There was no definite relation between UGT1A1 28, 6 polymorphisms and toxicity. However, homozygosity for UGT1A1 28 or UGT1A1 6 and double heterozygosity for both UGT1A1 28 and UGT1A1 6 were significantly associated with severe neutropenia in metastatic colorectal cancer patients (P< 0.001).
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2005 Year 10 Month 21 Day
Date of IRB
Anticipated trial start date
2005 Year 11 Month 01 Day
Last follow-up date
2009 Year 07 Month 01 Day
Date of closure to data entry
2009 Year 07 Month 01 Day
Date trial data considered complete
2009 Year 07 Month 01 Day
Date analysis concluded
2009 Year 07 Month 01 Day

Other
Other related information Jpn J Clin Oncol. 2011 Apr;41(4):477-82.
Prospective phase II study of FOLFIRI for mCRC in Japan, including the analysis of UGT1A1 28/6 polymorphisms.
Okuyama Y, Hazama S, Nozawa H, Kobayashi M, Takahashi K, Fujikawa K, Kato T, Nagata N, Kimura H, Oba K, Sakamoto J, Mishima H.

Management information
Registered date
2009 Year 08 Month 26 Day
Last modified on
2018 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002870

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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